Extensive damage occurred at the company’s property in Rocky Mount, and many products used by hospitals appeared to have been affected. This could further exacerbate shortages.A Pfizer facility and several homes sustained major damage when a tornado ripped through a 16-mile strip of Rocky Mount, N.C.By The Associated PressA tornado caused extensive damage to a Pfizer drug manufacturing site in Rocky Mount, N.C., on Wednesday, threatening critical supplies for hospitals across the country.The company estimated that one-fourth of the injectable medications it supplies to U.S. hospitals were made at the Rocky Mount property, including drugs used during surgeries and other procedures to help block pain, keep patients sedated and fight infections.Though the company has yet to disclose the extent of the storm’s impact, video footage of the site and interviews with the Nash County sheriff and with people briefed on the damage indicated that the tornado caused the worst damage at the company’s warehouse.On Thursday, Pfizer declined to comment on the drugs affected or the proportion of its supply destroyed in the tornado, which could be considerable given that a lot of these medications required careful production and handling to ensure sterility.It was also unclear how deeply the destruction would exacerbate existing national drug shortages, which have reached a 10-year high in recent months. Hospitals are on high alert because low-cost generic products manufactured at the site, are already among the most shortage-prone on the market.“From a health care practitioner point of view, I’m just holding my breath,” said Michael Ganio, a senior director at the American Society of Health-System Pharmacists.The tornado ripped through a 16-mile strip of the Rocky Mount area, about 50 miles east of Raleigh, at about 12:30 p.m. on Wednesday. It snapped trees at the base and tossed homes 20 yards from their foundations, according to a summary by the National Weather Service. The tornado reached wind speeds up to 150 miles per hour before it ripped off large pieces of the metal roof of a Pfizer building and flipped big-rig trucks in the parking lot. Sixteen people were injured, but no deaths were reported.Several people said the tornado caused the most damage to a company warehouse; the impact to the manufacturing plant — and its ability to continue producing medicines — is not yet clear, according to Mittal Sutaria, a senior vice president of pharmacy contracts at Vizient, which provides contracting for medications to hospitals.She said Pfizer had teams on-site to assess the damage.Dr. Sutaria, who said Vizient had been in touch with Pfizer, added that the Rocky Mount site made anesthesia products, as well as fentanyl and morphine, which are used in IVs for pain management. It also makes antibiotics administered to fight severe infections, and muscle blockers including succinylcholine, also used in surgery.Keith Stone, the sheriff of Nash County, where Rocky Mount is situated, told local news reporters on Wednesday that much of the Pfizer building was splintered, the roof was crushed and as many as 50,000 pallets of medicine were destroyed.About 100 vehicles were also damaged, including forklift trucks that were strewn across nearby railroad tracks, Sheriff Stone said in an interview on Thursday. “It’s just amazing what can come up so quick and have so much damage and be gone so fast,” he said.Steve Danehy, a spokesman for Pfizer, said on Thursday that the company’s Rocky Mount team was “working very hard to address and assess the situation,” but did not provide any details. The company said its staff survived the tornado without serious injuries.Pfizer is expected to report its findings to the Food and Drug Administration, which tracks shortages.“We are following the situation closely as it evolves and are working with the company to understand the extent of the damage and any potential impact to the nation’s drug supply,” said Chanapa Tantibanchachai, a spokeswoman for the agency.The Rocky Mount facility, established in 1968, employs 4,500 people and has 24 filling lines and 22 packing lines. Though not as large as Pfizer’s manufacturing complex in Kalamazoo, Mich., the North Carolina site spans 1.4 million square feet of manufacturing space. The medicines made at the site are also shipped to Japan, Canada, Brazil and other countries.The specific products made at the Pfizer plant — and the share of the market they comprise — is not typically public information. However, the company sells dozens of injectable items, including I.V. antibiotics, anti-seizure drugs used in brain surgery and even an antidote to coral snake venom.Many Pfizer medicines were already in short supply before the tornado: About 130 products marketed to hospitals were listed as “depleted” and about 100 more were in “limited supply,” according to the company’s list of 660 products.Pfizer has other manufacturing plants in Kansas, New York, Massachusetts and Wisconsin where the company could possibly shift some production to ease any shortages resulting from the Rocky Mount destruction.Soumi Saha, a senior vice president with Premier, a company that provides contracting services for medications to hospitals, said that Pfizer had a strong track record for building in some redundancy so that products were manufactured at more than one site.If the storm damage is limited to the warehouse and does not affect production schedules at the manufacturing plants, that could mitigate potential shortages, she said.Dr. Ganio recalled other drug shortages caused by disasters in production zones.Hurricane Maria struck Puerto Rico in 2017, leaving hospitals scrambling for IV bags. Another occurred last year when a region of China that was hard-hit by Covid had a lapse in producing contrast dye for CT scans and other medical images. And in recent months, doctors have warned that survival rates for some cancer patients are in jeopardy because of a halt in production at a manufacturing plant in India after the F.D.A. cited major quality lapses.Given the worrisome shortages that affect so many lives — and that have resulted in hoarding of certain drugs and bartering among advocates who trade and find scarce drugs for the most desperate — policy experts, lawmakers and federal officials have been discussing solutions in recent weeks.On Thursday, Senate lawmakers passed a pandemic preparedness bill out of a key health committee. It had provisions aimed at stemming shortages and increasing reports by drugmakers to alert the F.D.A. to circumstances that might lead to shortages so the agency could help head them off. The bill would also require a report from the F.D.A. within 90 days of the legislation’s passage on the agency’s ability to deal with shortages and whether it needs more help from lawmakers.Still, the natural occurrence of a tornado provided a stark reminder of the need to better manage shortages.“This reinforces the need for resiliency in our supply chain and a true focus on preparedness, not only for the next pandemic,” Dr. Saha said, “but for any unforeseen circumstance that creates shocks in our supply chain.”

The respiratory virus is a global killer of babies and young children.The Food and Drug Administration on Monday approved a shot to protect infants and vulnerable toddlers against respiratory syncytial virus, or R.S.V., offering one of the first protections for an illness that fills children’s hospitals year after year.The monoclonal antibody shot is expected to be available at the start of the fall R.S.V. season. The F.D.A. is also considering approval of an R.S.V. vaccine by Pfizer for pregnant women that is meant to protect infants from the virus.The treatment approved on Monday, called Beyfortus by its developers Sanofi and AstraZeneca, addresses an illness that can be severe in older adults and young infants. About 80,000 children ages 5 and younger are hospitalized with the virus each year, according to the Centers for Disease Control and Prevention.“R.S.V. can cause serious disease in infants and some children and results in a large number of emergency department and physician office visits each year,” Dr. John Farley, an official in the F.D.A. Center for Drug Evaluation and Research, said. “Today’s approval addresses the great need for products to help reduce the impact of R.S.V. disease on children, families and the health care system.”The potential to blunt the effects of R.S.V. will extend to older adults: In recent months, the F.D.A. has approved two vaccines against the virus for adults 60 and older. The virus is linked to 60,000 hospitalizations and up to 10,000 deaths each year in people 65 and older, according to the C.D.C. The agency estimated that more than 21,000 people in that age group would need to take the GSK vaccine to prevent one R.S.V. death in one year; the number was nearly 25,000 for the Pfizer shot.Agency advisers considering the antibody shot for infants cast a unanimous vote in June in favor of approving the treatment for infants. More than 3,200 infants were given the shot in studies that Sanofi and AstraZeneca submitted to the F.D.A. One six-month study found that efficacy against very severe R.S.V. that required medical attention was 79 percent.F.D.A. advisers were more cautious about an R.S.V. shot by Pfizer intended for pregnant women. In May, a panel voted 10 to 4 that the vaccine was safe, a reflection of concerns about slightly elevated rates of preterm births among mothers who received the vaccine, compared with those who received a placebo.Studies of a similar vaccine by GSK were halted after researchers detected an increase in preterm births. The agency has yet to make a decision on that maternal Pfizer vaccine, called Abrysvo, though a company spokeswoman said that approval was anticipated in the coming weeks.

The F.D.A. and the powerful beverage industry protested the new findings, and a second W.H.O. group stood by its standard that the sweetener is generally safe.A World Health Organization agency declared on Thursday that aspartame, an artificial sweetener widely used in diet drinks and low-sugar foods, could possibly cause cancer.A second W.H.O. committee, though, held steady on its assessment of a safe level of aspartame consumption. By some calculations using the panel’s standard, a person weighing 150 pounds could avoid a risk of cancer but still drink about a dozen cans of diet soda a day.The declaration by a W.H.O. agency of a cancer risk associated with aspartame reflects the first time the prominent international body has weighed in publicly on the effects of the nearly ubiquitous artificial sweetener. Aspartame has been a contentious ingredient for decades.The International Agency for Research on Cancer, or I.A.R.C., said it based its conclusion that aspartame was a possible carcinogen on limited evidence from three observational studies of humans that the agency said linked consumption of artificially sweetened beverages to an increase in cases of liver cancer — at levels far below a dozen cans a day. It cautioned that the results could potentially be skewed toward the profile of people who drink higher amounts of diet drinks and called for further study.Still, people who consume high amounts of aspartame should consider switching to water or other unsweetened drinks, said Dr. Francesco Branca, director of the W.H.O. Department of Nutrition and Food Safety.But, he added: “Our results do not indicate that occasional consumption should pose a risk to most.”Concerns about rising global rates of obesity and diabetes as well as changing consumer preferences have resulted in an explosion of no- and low-sugar food and beverages. Aspartame, one of six sweeteners approved by U.S. regulators, is found in thousands of products, from packets of Equal to sugar-free gum, diet sodas, teas, energy drinks and even yogurts. It is also used to sweeten various pharmaceutical products.The U.S. Food and Drug Administration, which approved aspartame decades ago, on Thursday issued an unusual criticism of the global agency’s findings and reiterated its longstanding position that the sweetener is safe. In a statement, the F.D.A. said it “disagrees with I.A.R.C.’s conclusion that these studies support classifying aspartame as a possible carcinogen to humans.”The F.D.A. also said that “aspartame being labeled by the W.H.O. as ‘possibly carcinogenic to humans’ does not mean that aspartame is actually linked to cancer.” The F.D.A. declined to make any of its experts available for interviews to discuss the agency’s specific concerns.But its salvo against the international organization was sure to ignite further debate in Europe — where the sweetener is still deemed safe — and renew review in the United States. And the dueling global agencies’ pronouncements are likely to fuel confusion among consumers.The W.HO. has occasionally been out of step with other authorities on potential cancer risks, like glyphosate, and later led the way toward establishing that it was dangerous to human health. The international body’s designation of a cancer link to that ingredient in Roundup, a weed killer, became the stepping stone for lawsuits against the makers of the herbicide.Around the world, the powerful beverage industry has fought long and hard against any regulatory or scientific finding that tied artificial sweetener use to risks of cancer or other health problems. Aspartame is only the latest battleground for multinational companies to push back against new studies or potential links to health risks.Researchers in the Cesare Maltoni Cancer Research Center in Bologna, Italy, in 2006. Italian researchers conducting rodent studies from 2005 to 2010 rekindled the debate over aspartame.Pigi Cipelli for The New York Times“Aspartame is safe,” Kevin Keane, interim president of the American Beverage Association, said in a statement. He cited the dueling W.H.O. announcements, singling out the second panel, the Joint Expert Committee on Food Additives, that performed a concurrent review and left its recommended daily intake amount unchanged. It also deemed the evidence for cancer in humans “not convincing,” a W.H.O. summary shows.“After a rigorous review, the World Health Organization finds aspartame is safe and ‘no sufficient reason to change the previously established acceptable daily intake,’” Mr. Keane said. “This strong conclusion reinforces the position of the F.D.A. and food safety agencies from more than 90 countries.”Coca-Cola referred questions to the American Beverage Association and PepsiCo did not respond to requests for comment.The safety of sugar replacements, including the decades-old science dispute over the use of saccharin in the diet drink Tab, has been heavily scrutinized. Once linked to bladder cancer in rats, Congress mandated further study of saccharin. Since then, according to the F.D.A., 30 studies showed the rodent results did not apply to humans; U.S. officials removed saccharin from a list of potential carcinogens. More recently, other sweeteners have come under scrutiny for their ties to possible health risks.At the center of the dispute over aspartame are rodent studies from 2005-2010 by Italy-based researchers that showed a link to cancer. The F.D.A. has dismissed the long-debated studies as “compromised.”Dr. William Dahut, chief scientific officer of the American Cancer Society, which led one of the key studies the W.H.O. relied on, said the findings should be considered alongside the W.H.O.’s report earlier this year that indicated artificial sweeteners offered no help in achieving weight loss or protection from other chronic conditions.He said there was little evidence now to suggest a daily Diet Coke would elevate the risk of cancer, adding that “more research is needed.” Overall, he said, the science was more definitive on reducing cancer risk by avoiding tobacco, alcohol, processed meat and excess body weight.The I.A.R.C. said it could not rule out the possibility that the studies linking aspartame to liver cancer were a result of chance or other factors associated with drinking diet soda.The W.H.O.’s cancer agency has four categories: carcinogenic, probably carcinogenic, possibly carcinogenic and no classification. Those levels reflect the strength of the science rather than how likely the substance is to cause cancer.The other W.H.O. group on food additives recommended that daily consumption should be below 40 milligrams of aspartame per kilogram of a person’s weight — slightly lower than the suggested U.S. level of 50 milligrams.The F.D.A. said it estimated that a person weighing 132 pounds would need to consume 75 packets of aspartame sweetener to reach the threshold of exposure to a potential risk.For its review of aspartame, the I.A.R.C. convened 25 cancer experts from 12 nations in Lyon, France, to conduct the review of existing studies. It concluded that there was limited evidence for cancer in humans based on three studies linking artificially sweetened drinks to increases in hepatocellular carcinoma, the most common type of liver cancer.One study in 2016 was led by W.H.O. officials, who looked at nearly 500,000 people in Europe who were followed for about 11 years. The study tracked participants’ juice and soft drink intake and the relationship to liver and bile duct cancers. It examined those who drank artificially sweetened soft drinks and found that each additional serving of diet soft drink a week was associated with a 6 percent increased risk of liver cancer.A U.S. study published last year by researchers from Harvard, Boston University and the National Cancer Institute examined sweetened beverage consumption reported by people on questionnaires and cancer case registries. Researchers found an elevated risk of liver cancer in people with diabetes who said they consumed two or more artificially sweetened sodas a day. That study found no increase in liver cancer among diet soda drinkers who did not have diabetes.The F.D.A., which approved aspartame decades ago, responded strongly to the I.A.R.C.’s conclusions.Andrew Harnik/Associated PressA third study, led by the American Cancer Society, examined the use of beverages sweetened by sugar and artificial sweeteners and cancer death data. It found a 44 percent increase in liver cancer among men who never smoked and drank two or more artificially sweetened drinks a day. Even adjusting for high body mass — in itself a cancer risk factor — the men had a 22 percent increase in risk, data in a supplement to the study shows.The American Beverage Association, which represents Coca-Cola and PepsiCo, has been vocal in saying that the W.H.O.’s food additive panel — not the cancer experts — should be the lead authority evaluating aspartame.In recent weeks, the beverage industry trade group has financed a new coalition led by Alex Azar, an appointee of former President Donald J. Trump, and Donna Shalala, an appointee of former President Bill Clinton. Both Mr. Azar and Ms. Shalala were former secretaries of the Department of Health and Human Services. In an opinion article in Newsweek earlier this month, the two embraced the F.D.A.’s position on the safety of aspartame, and called the agency “the world’s gold standard for independent regulatory bodies.”The trade group had previously contested another review of aspartame’s potential links to cancer in California. In 2016, a state committee discussed reviewing aspartame, but it went no further.California officials said this week that the state could review the latest W.H.O. decision.Besides aspartame, the W.H.O.’s cancer agency has deemed other possible carcinogens to range from the seemingly benign, like Ginkgo biloba extract and aloe vera leaf extract, to the more concerning, like gasoline exhaust and perfluorooctanoic acid, the most common of the industrial chemicals known as per- and polyfluoroalkyl substances, or PFAS, that has recently been subject to billion-dollar settlements over drinking water contamination.In deeming aspartame a possible carcinogen, the I.A.R.C. also dipped into one of the central controversies of aspartame research. It concluded that there was some evidence for cancer in lab animals based on studies performed by the Ramazzini Institute in Italy, citing the group’s finding of increased tumors in aspartame studies from the mid-2000s. Based on concerns over the group’s methods and interpretations, though, the findings were deemed limited.For its part, the Ramazzini Institute said in 2021 that its work on aspartame was validated and that its earlier findings were “savagely attacked by the chemical manufacturing and processed food industries and by their allies in regulatory agencies.”Dr. Branca of the W.H.O. responded to questions about the need for an I.A.R.C. review during a news conference on Wednesday, saying that 10 million people die of cancer each year. “So there’s a societal concern that our organization needed to respond to,” he said.He said the results demonstrated a clear need for further high-quality research.“We’ve in a sense raised a flag here, indicating that we need to clarify much more in the situation,” Dr. Branca said. “It is not something which we can dismiss at this moment.”Julie Creswell contributed reporting to this article.

Tony Shepard learned he had vocal cord cancer this spring, but he was encouraged when his doctor said he had an 88 percent chance at a cure with chemotherapy and radiation.That outlook began to dim in recent weeks, though, after the oncology practice he goes to in Central California began to sporadically run out of the critical medication he needs.Since Mr. Shepard’s doctor informed him of the shortage, each treatment session has felt like a game of “Russian roulette,” he said, knowing that failure would mean the removal of his vocal cords and the disappearing of his voice.“I try not to even think about it,” said Mr. Shepard, 62, a manager of a gas station in Madera, a town in California’s Central Valley. “It’s something scary that you don’t really want to think about — but you know it’s a reality.”The nation’s monthslong shortage of highly potent cancer drugs is grinding on, forcing patients and their doctors to face even grimmer realities than those cancer typically presents. Thousands of patients like Mr. Shepard have been confronting gut-wrenching options, delays in treatment and potentially bleaker futures.Oncologists are concerned that the alternatives to two crucial chemotherapy drugs are far less effective in treating certain cancers, and are sometimes more toxic. The backup therapies or lack thereof, they say, pose particularly troubling prospects for patients with ovarian, testicular, breast, lung and head and neck cancers.There are few, if any, signs that the shortage will ease anytime soon. A plant that was a main producer of the more popular drugs shut down late last year and has not reopened, depleting its stock. The easing of restrictions on imported drugs from China this month has provided some relief, but doctors said the influx has yet to make much of a dent. Some companies that sell the medications are projecting that the shortage will last through the fall or later.So far, neither a group of experts organized by the Biden administration nor prominent medical organizations have found a way to avoid rationing the crucial chemo drugs.To bridge the gaps, some doctors are extending care intervals and skimming precious milliliters to stretch doses. Others are turning to a strategy of surgery first and chemo later, banking on a resumption of supplies.One of the nation’s top cancer care groups, the American Society of Clinical Oncology, is now advising doctors with low quantities of the medications to administer them to patients with a shot at a cure — and to deny them to patients with recurrent or widely spread disease.​​ “We’re in a situation where patients are being left behind, and we’re really worried survival could be affected by the chemotherapy shortage,” said Dr. Angeles Alvarez Secord, president of the Society of Gynecologic Oncology and a professor at Duke University School of Medicine.Two main chemotherapy drugs, cisplatin and carboplatin, are deployed as frontline medicines in cocktails used to shrink or eliminate tumors. More than a dozen cancer drugs are also officially in short supply, as well as hundreds of other medications, including antibiotics and sterile injectable fluids. Still, doctors predict that the absence of the powerful chemotherapies may hurt patients most.Cisplatin and carboplatin are inexpensive: They cost $15 and $23 per vial, according to the U.S. Pharmacopeia, a nonprofit aimed at medication safety and supply. But manufacturing the drugs requires a reliable supply of platinum, a metal used, as well as a sterile plant and special controls to protect workers from the drugs’ toxic effects. As a result, few companies make them.A cisplatin injection box in the pharmaceutical storage room at the Center for Cancer and Blood Disorders in Fort Worth, Texas.Emil Lippe for The New York TimesThe most recent shortages of these widely used drugs occurred when a leading manufacturer, Intas Pharmaceuticals, shut down production in December after the Food and Drug Administration had performed a surprise inspection at its plant in Ahmedabad, India. The U.S. agency issued a report that said employees were shredding, tearing and pouring acid on quality control records and noted a “cascade of failure” at the site.The company’s subsidiary, Accord Healthcare, in Durham, North Carolina, said recently that it was still making improvements at the plant that were needed to restart production.By this spring, the effects of the Intas shutdown were deeply felt. A survey by the National Comprehensive Cancer Network of academic treatment centers released earlier this month found that 93 percent of the 27 centers that responded were experiencing a carboplatin shortage. As a result, 36 percent of them reported altering treatments for their patients, resorting to lower doses and longer intervals between therapies.At cCare Cancer Center in Fresno, Calif., where Mr. Shepard receives care for his vocal cord cancer, efforts to stretch supply have given way to sporadic availability. For the last six weeks, vials of the platinum drugs have been unavailable roughly half of the time, an oncologist, Dr. Ravi Rao, said.He said Mr. Shepard’s odds of a cure without the drugs would fall from roughly 90 percent to about 45 percent. Fortunately, Mr. Shepard said, the drugs have been available for the first two of seven treatments.Patients with ovarian cancer are facing the worst outlook, Dr. Rao said, because of how common the disease is and how central the platinum drugs have been in tackling it for decades. Without those drugs, one patient with extensive ovarian cancer has odds of survival that fall to the single digits from about 30 percent, he said.“This shortage will lead to people dying,” said Dr. Rao, who is also a board member of the Community Oncology Alliance. “There’s just no way around it. You cannot remove these lifesaving drugs and not have bad outcomes.”Others who face heightened threats are patients with testicular cancer, because cisplatin has a known record of curing even advanced cases, said Dr. Julie Gralow, the ASCO chief medical officer, in her testimony to a House subcommittee earlier this month.“This is critical, impacting maybe as many as half a million Americans with just these two drugs,” Dr. Gralow said.Arias Pitts, a single mother living in Tampa, Fla., was diagnosed with an aggressive breast cancer in April and encountered the shortage at her first treatment last month.Octavio Jones for The New York TimesFor Florida Cancer Specialists, with more than 90 sites, the shortage initially meant conserving 10 to 15 percent of a patient’s dose to stretch stock, said Dr. Lucio Gordan, president of the practice.That was not enough, so doctors began to only give the drugs to patients with a chance at a cure or those enrolled in clinical trials. The practice found some products at vastly inflated prices — apparent price gouging — but bought them anyway.Still, by May, the practice was without carboplatin for 12 days and cisplatin for eight days, Dr. Gordan said.Arias Pitts, 33, who was diagnosed with an aggressive breast cancer in April, encountered the shortage when she arrived to begin treatment on May 16. The carboplatin her doctor had ordered for the first of six rounds of chemotherapy was not available.“Of course I had questions and concerns,” said Ms. Pitts, an academic adviser at the University of South Florida and a single mother of a 4-year-old. She added: “It’s stressful.”The F.D.A. has taken steps to ease the shortage. It oversaw the testing and release of batches of the platinum drugs manufactured by Intas in India that were made before the shutdown, but that stock has now been exhausted.It is also temporarily allowing Qilu Pharmaceuticals, based in China, to ship its cisplatin to the United States.Jordan Berman, a vice president of Apotex Pharmaceuticals, a Toronto company importing the Qilu drugs, said it received shipments of cisplatin on June 6 and began routing them through major U.S. distributors.Oncologists and supply chain experts said there was little data so far to gauge the effect the imports would have. About 600 vials of cisplatin from China arrived at Florida Cancer Specialists earlier this month, Dr. Gordan said. But that was not enough for the practice to resume offering the drugs to patients with advanced or recurrent cancers.“It’s about six days of treatment for us,” Dr. Gordan said. “We’re scrambling.”Studies in the 1980s and 90s showed that the platinum drugs were a vast improvement over existing treatments, performing best in combination with other drugs and doubling the response rates for ovarian and head and neck cancer. The platinum drugs pushed the five-year survival rate for testicular cancer to 95 percent from roughly 10 percent.While newer immunotherapy treatments have improved the outcome for patients with certain types of cancer, like melanoma, oncologists also include them in cocktails with the platinum drugs to extend their lives and enhance the potential for survival.“In general, we haven’t seen these home runs in cancer” in recent years, said Dr. Mikkael Sekeres, a University of Miami oncologist and former F.D.A. oncology adviser.Oncologists advising the field amid the current shortages have urged those treating early-stage lung cancer patients to send them to a center that has the drugs, noting, “there are no equally effective alternatives.”Dr. Evan Myers, a Duke University researcher in the obstetrics and gynecology department, said he was planning to measure the effects of the shortages. One study of a different medication shortage affecting children and adolescents with Hodgkin’s lymphoma found that the substitute drug was “significantly less effective,” and reduced the survival rate for the young people who received the backup treatment.Dr. Myers said this year’s shortages would, at a minimum, likely have an effect on the quality of life for people undergoing treatment. “They’re going to be waiting for the other shoe to drop,” he said.Dr. Prasanthi Ganesa at the infusion center of the Center for Cancer and Blood Disorders in Fort Worth. “We feel really helpless,” she said.Emil Lippe for The New York TimesDoctors are also struggling with how to convey such devastating news, said Dr. Prasanthi Ganesa, medical director of The Center for Cancer and Blood Disorders in Fort Worth. Her practice is looking at each case individually, but is also prioritizing crucial doses for patients who could potentially be cured.“I can imagine a patient listening to this and saying, ‘You know, I am trying to live longer, that is my priority. So I need that drug, doc,’” she said. “We feel really helpless.”The situation demands action, said Dr. Karen Knudsen, chief executive of the American Cancer Society. The White House and Congress, which have discussed the problem, have advanced few concrete solutions.“The necessity for a durable solution is growing greater by the day,” Dr. Knudsen said, adding, “Patients are left hanging.”

The NewsSales of e-cigarettes rose by nearly 47 percent from January 2020, just before the pandemic hit the United States, to December 2022, according to an analysis released on Thursday by the Centers for Disease Control and Prevention.The increase over that period occurred while teenagers and young adults reported in surveys that they had recently tried e-cigarettes at much higher rates than older adults did.According to the C.D.C., about 4.5 percent of all adults said they used e-cigarettes. But the rates went up as the age dropped. About 14 percent of high school students and 11 percent of young adults reported using the devices within the last 30 days of the survey, the C.D.C. data showed.Sales were still growing through May of last year, but then dropped by 12 percent through December. Researchers attributed the decline to several possible factors, including state or local bans on flavored products; government enforcement; and the introduction of devices that offered thousands of “puffs” in a single device.Overall, four-week sales of e-cigarettes climbed to 25.9 million units late last year, from 15.5 million units in early 2020.A health warning accompanies the display of Vuse e-cigarettes.Michael M. Santiago/Getty ImagesWhy It Matters: Effects of vaping are still unknownThe Food and Drug Administration has embraced the use of e-cigarettes, regulating their sale on the market as an aid for adult smokers to make the transition to a less harmful product.But tobacco opponents and public health experts warn that the popular devices have lured teenagers and young people — who would be unlikely to smoke traditional cigarettes — into an addictive habit amid growing concerns about vaping nicotine.The C.D.C.’s analysis reinforces data indicating that fruit and candy flavors have surged in popularity. The vaping devices often contain high levels of nicotine and are sold in appealing colors and flavors, like strawberry ice cream and mango ice.The American Heart Association has called for more action to reduce youth vaping and issued a scientific statement last year saying that e-cigarettes appeared to lead to increased risk of heart and lung disease. The American Lung Association has also aired concerns, saying it was “very troubled by the evolving evidence about the impact of e-cigarettes on the lungs” and citing the known and unknown toxic effects of chemicals used in vapes.Background: Youth vaping was on the riseThe C.D.C. study does not include sales from vaping and tobacco shops or internet sales, so the findings are limited.Still, trends have shifted in the last few years. Vaping of e-cigarettes among minors has declined from a record high in 2019, when nearly 28 percent of high school students reported vaping within the last 30 days. At the time, products that were sleek and produced by Juul Labs were the most popular, and the company was largely blamed for the soaring rate of teenage vaping. Juul has since resolved myriad lawsuits brought by many states and individuals, resulting in settlements adding up to nearly $3 billion.The F.D.A. has rejected applications for millions of products to get on the market, approving only about two dozen tobacco-flavored vaping devices. Yet the agency has struggled with enforcement; flavored vapes have flooded gas stations, convenience stores and vape shops nationwide.The agency prevailed in court in recent weeks against the makers of Hyde vapes, which were a favorite among high school students in a recent youth tobacco survey. The latest report from the C.D.C. shows Elf Bar Vapes rising in popularity. The F.D.A. has issued an import alert for them to be seized at the border and on Thursday announced enforcement against nearly 200 retailers selling those vapes and Esco Bar products.What’s Next: Regulation and enforcementThe F.D.A. has said it will issue final decisions by the end of this year on the remaining applications for selling vaping products to address the top sellers by Vuse, Juul and others.Tobacco control advocates are pressuring the F.D.A. to step up its enforcement of unauthorized e-cigarettes and to also move forward with a proposed ban on menthol cigarettes.Many interested parties are also watching the effects of a statewide flavor ban unfolding in California — one similar to those in six other states and more than 300 jurisdictions. Since Dec. 21, when the ban took effect, vape product sales fell 35 percent through late March, according to data from the C.D.C. Foundation.

An F.D.A. advisory panel told manufacturers to aim the latest coronavirus vaccine for the fall at the dominant SARS-CoV-2 variant.The NewsVaccine makers should target the XBB variant of the coronavirus in a shot to be available in the fall, moving away from the existing formula that protected against the Omicron variant and an early form of the virus, an advisory panel to the Food and Drug Administration agreed on Thursday.The 21-member panel unanimously recommended that manufacturers should aim at the most dominant variant of the coronavirus this summer. If the F.D.A. agrees, the advice would start the manufacturing of millions of shots.Agency officials had earlier said they hoped to move toward an annual vaccine against the coronavirus. But the discussion on Thursday did not involve any timetables as to how often adults should receive new shots, or which populations should be offered the latest vaccine, though the initial advice last fall was for those age 12 and older to get the shot.Jim Wilson/The New York TimesWhy It Matters: Some people remain at risk.Pfizer, Moderna and Novavax have made it clear that they need time to make tens of millions of doses of the shots that would be available in the fall.“I think that’s what today’s discussion is about — how to best to come up with what goes into people’s arms to offer the best protection during a period when we think we’ll have waning immunity,” said Dr. Peter Marks, the F.D.A.’s vaccine chief. He added that the winter may also bring “further evolution of the virus.”Since the beginning of the pandemic, 6.2 million hospitalizations and 1.1 million deaths have been attributed to the virus in the United States, according to data presented by Natalie Thornburg, a vaccine expert at the Centers for Disease Control and Prevention.She said the picture had improved this year, but those who remain vulnerable include the unvaccinated, people who are immunocompromised and those who have diabetes or chronic kidney, lung, cardiovascular or neurologic diseases. People 65 and older are also at risk, and that rises with age.Background: Changes are afoot in who gets the shots and when.The bivalent shots offered last fall included protection against the Omicron variant and an early Covid variant. About 20 percent of adults, or about 53 million, in the United States got the booster shot, with the rates higher among older adults.Moving ahead with a shot targeted at only an XBB variant means that newborns and people with compromised immune systems may not have immunity against the earliest coronavirus variants. That should not be a problem, according to a briefing given by a World Health Organization official, who said those variants were no longer in circulation.What’s Next: A vaccine may be offered alongside flu and R.S.V. jabs.The F.D.A. is expected to make a more official recommendation to vaccine makers soon. The manufacturers will be expected to study the new formulas and submit data to the agency. If approvals are granted, the C.D.C. will advise health providers on which age groups should get the jab.An F.D.A. spokesman said it expected that an updated vaccine would be available by late September, assuming the data support safe and effective vaccines.It remains unclear whether or when the vaccine makers or the F.D.A. will examine the potential effects of administering multiple vaccines in the fall, including those for the flu and respiratory syncytial virus, or R.S.V., which are expected to be available for pregnant people and older adults. Agency advisers have also endorsed the use of an R.S.V. antibody shot to protect infants.

An F.D.A. advisory panel told manufacturers to aim the latest coronavirus vaccine for the fall at the dominant SARS-CoV-2 variant.The NewsVaccine makers should target the XBB variant of the coronavirus in a shot to be available in the fall, moving away from the existing formula that protected against the Omicron variant and an early form of the virus, an advisory panel to the Food and Drug Administration agreed on Thursday.The 21-member panel unanimously recommended that manufacturers should aim at the most dominant variant of the coronavirus this summer. If the F.D.A. agrees, the advice would start the manufacturing of millions of shots.Agency officials had earlier said they hoped to move toward an annual vaccine against the coronavirus. But the discussion on Thursday did not involve any timetables as to how often adults should receive new shots, or which populations should be offered the latest vaccine, though the initial advice last fall was for those age 12 and older to get the shot.Jim Wilson/The New York TimesWhy It Matters: Some people remain at risk.Pfizer, Moderna and Novavax have made it clear that they need time to make tens of millions of doses of the shots that would be available in the fall.“I think that’s what today’s discussion is about — how to best to come up with what goes into people’s arms to offer the best protection during a period when we think we’ll have waning immunity,” said Dr. Peter Marks, the F.D.A.’s vaccine chief. He added that the winter may also bring “further evolution of the virus.”Since the beginning of the pandemic, 6.2 million hospitalizations and 1.1 million deaths have been attributed to the virus in the United States, according to data presented by Natalie Thornburg, a vaccine expert at the Centers for Disease Control and Prevention.She said the picture had improved this year, but those who remain vulnerable include the unvaccinated, people who are immunocompromised and those who have diabetes or chronic kidney, lung, cardiovascular or neurologic diseases. People 65 and older are also at risk, and that rises with age.Background: Changes are afoot in who gets the shots and when.The bivalent shots offered last fall included protection against the Omicron variant and an early Covid variant. About 20 percent of adults, or about 53 million, in the United States got the booster shot, with the rates higher among older adults.Moving ahead with a shot targeted at only an XBB variant means that newborns and people with compromised immune systems may not have immunity against the earliest coronavirus variants. That should not be a problem, according to a briefing given by a World Health Organization official, who said those variants were no longer in circulation.What’s Next: A vaccine may be offered alongside flu and R.S.V. jabs.The F.D.A. is expected to make a more official recommendation to vaccine makers soon. The manufacturers will be expected to study the new formulas and submit data to the agency. If approvals are granted, the C.D.C. will advise health providers on which age groups should get the jab.An F.D.A. spokesman said it expected that an updated vaccine would be available by late September, assuming the data support safe and effective vaccines.It remains unclear whether or when the vaccine makers or the F.D.A. will examine the potential effects of administering multiple vaccines in the fall, including those for the flu and respiratory syncytial virus, or R.S.V., which are expected to be available for pregnant people and older adults. Agency advisers have also endorsed the use of an R.S.V. antibody shot to protect infants.

The NewsA Food and Drug Administration advisory panel recommended approval of a monoclonal antibody shot aimed at preventing a potentially lethal pathogen, respiratory syncytial virus, or R.S.V., in infants and vulnerable toddlers.The treatment, called Beyfortus by its developers Sanofi and AstraZeneca, would be the second such therapy that the F.D.A. has allowed to be given to very young children to prevent R.S.V., which is a leading killer of infants and toddlers globally. A similar treatment approved more than 20 years ago is given in multiple doses and is only approved for high-risk infants.The 21-member panel voted unanimously in favor of giving the treatment to infants born during or entering their first R.S.V. season. The advisers voted 19-2 for giving the shot to children up to 24 months of age who remain vulnerable to severe disease.Up to 80,000 children younger than 5 are hospitalized annually in the United States with respiratory syncytial virus and up to 300 die. Marijan Murat/dpa, via ReutersWhy It Matters: R.S.V. is a global killer of infants.Though many people experience this common virus as a routine cold, it can be serious in young infants and older adults. According to the Centers for Disease Control and Prevention, up to 80,000 children younger than 5 are hospitalized with the virus each year and up to 300 die. R.S.V. played a role in filling children’s hospitals during this winter’s “tripledemic,” which also included the flu and Covid-19.For adults 65 and older, as many as 160,000 hospitalizations are attributed to R.S.V., and about 10,000 deaths. Vaccines for older adults have also recently been approved.Background: The shot’s safety will be monitored.More than 3,200 infants were given the antibody shot during studies provided to the F.D.A. by the drugmakers, including one that found that after six months, efficacy against very severe R.S.V. that required medical attention was 79 percent.A separate agency panel has recommended approval of a maternal R.S.V. vaccine that is also under review. Some of the advisers raised concerns about data for that vaccine, and for another like it that suggested a small increase in preterm births.If the antibody therapy is approved, the F.D.A. said it would continue to monitor the treatment for safety using several data sources. AstraZeneca said it would also conduct periodic safety reviews using worldwide data.What’s Next: The C.D.C. will review shots for mothers and babies.If the agency approves the new shot, it will likely become available in the fall — around the same time that the Pfizer R.S.V. vaccine given during pregnancy called Abrysvo goes on the market.The C.D.C. is expected to advise health providers on the use of the new treatments later this month. Families and their doctors could then choose a course of treatment that would take into account the timing of a birth and the winter R.S.V. season, among other factors.The F.D.A. said there was no study of the risks or benefits of women taking the maternal R.S.V. vaccine and giving the antibody shots to their infants.

A committee of experts voted in favor of a new shot administered to pregnant women, one in a series of new ways to arm the very young against a life-threatening virus.An advisory panel to the Food and Drug Administration voted on Thursday in favor of approving a vaccine by Pfizer to prevent the severe respiratory virus that is a potentially deadly threat to infants.The vaccine would be the first to protect babies from respiratory syncytial virus, or R.S.V., which is the reason many infants are admitted to children’s hospitals each year and kills several hundred under 5 each year.Fourteen agency advisers unanimously agreed that the vaccine was effective, and the F.D.A. typically follows the recommendations of its advisory panels.Ten of the 14 agreed that the vaccine was safe, with some airing concerns about elevated rates — not all statistically significant — of preterm births among mothers who got the vaccine compared to those who received a placebo.The vote follows the F.D.A.’s earlier decision to approve the first R.S.V. vaccine for older adults in the United States. Several other options are still being evaluated.The Pfizer vaccine for pregnant women, called Abrysvo, is being reviewed ahead of another option submitted to the F.D.A. that would be given to infants — a monoclonal antibody shot meant to provide five months of protection.R.S.V. is a common ailment that is most severe in young infants and older adults. According to the Centers for Disease Control and Prevention, up to 80,000 children younger than 5 are hospitalized with the virus each year and up to 300 die. (As many as 160,000 adults 65 and older are hospitalized each year with the virus, and about 10,000 die.)The youngest infants face the greatest risk. Data presented at the meeting showed that infants 6 months or younger were twice as likely to be hospitalized compared with older babies or children. Efforts to test a vaccine in infants began in the 1960s but were abandoned when the vaccine caused more severe cases, said Dr. Bill Gruber, the head of clinical vaccine research and development at Pfizer.The prospect of having a large number of babies immunized in the fall, before the winter when R.S.V. rates are typically highest, would be “huge,” said Dr. Jonathan Miller, a pediatrician who sees children in the clinic and hospital for Nemours Children’s Health, Delaware Valley.“I’m thrilled about the prospect of this, as well as about the prospect of other R.S.V. vaccines in the pipeline,” said Dr. Miller, who is not an adviser to the agency. “This looks as if it will be the first one coming our way, and it’s a long time coming.”The vaccine under review Thursday was tested in about 7,300 women after the 24th week of pregnancy. About half received a placebo, and half were given the vaccine as a shot. For the first 90 days after birth, six infants in the vaccination group had a serious case of R.S.V., compared with 33 in the placebo group, translating to an efficacy of nearly 82 percent.The study, published in The New England Journal of Medicine, showed that for six months after birth, the vaccine was 69 percent effective. In the treatment group, 19 babies fell seriously ill compared to 62 in the placebo group.The main safety concern during the hearing was whether the vaccine was linked to preterm birth, a safety signal that led GSK to halt its trial of a similar R.S.V. vaccine that was being tested in pregnant patients, according to Dr. Hal Barron, a former company executive. The F.D.A. approved that vaccine, called Arexvy, for older adults earlier this month. (Like GSK, Pfizer tested the same vaccine formula in older adults and infants.)“We quickly halted the trial based on it confirming that the signal was real,” Dr. Barron said in a March 2022 presentation to investors, “but we are still puzzled as to exactly why this occurred.”The label for the GSK vaccine says that in tests of pregnant women, 6.8 percent receiving the treatment had preterm births, compared to 5 percent in the placebo group.In the Pfizer study, premature delivery was reported in 5.6 percent of the pregnancies in the treatment group, compared with 4.7 percent in the placebo group. Officials at the F.D.A. reported that the difference was not statistically significant.Pfizer said if the drug were approved, the company would conduct a post-approval study of real-world use of the vaccine, monitoring health records for the incidence of preterm birth and other possible problems. Agency advisers, though, expressed skepticism about a plan to use data generated from health care billing records to monitor vaccine safety. Several noted that such data could make it hard to link a parent who got the vaccine to the child.“I do feel like we should be setting the bar higher for review,” said one adviser, Dr. Amanda Cohn, the director of the division of birth defects and infant disorders at the C.D.C., adding that more data might help clarify questions about the effects on preterm birth.Dr. Hana El Sahly, the advisory committee chairwoman and professor of virology at Baylor College of Medicine, said the number of preterm births among those given the vaccine in a prior Pfizer study, in the main study under review and in the GSK study of a similar product were concerning, particularly given that the United States is not in the midst of an R.S.V. outbreak. She said the pattern should have been examined more carefully.“That was a big missed opportunity and I feel it’s unfair that we kicked the can down the road to the larger public,” said Dr. El Sahly, who voted “no” to the question about whether the safety data was adequate.There is another remedy under regulatory consideration, a monoclonal antibody shot developed by Sanofi and AstraZeneca, called nirsevimab. It is meant to be given at the hospital to babies who are born during the winter or in the fall, Jonathan Heinrichs, a Sanofi executive said in an interview.The medication is under F.D.A. review and was found in one study of nearly 2,500 infants to reduce cases of severe R.S.V. by 75 percent.

A worrisome scarcity of cancer drugs has heightened concerns about the troubled generic drug industry. Congress and the White House are seeking ways to address widespread supply problems.Thousands of patients are facing delays in getting treatments for cancer and other life-threatening diseases, with drug shortages in the United States approaching record levels.Hospitals are scouring shelves for supplies of a drug that reverses lead poisoning and for a sterile fluid needed to stop the heart for bypass surgery. Some antibiotics are still scarce following the winter flu season when doctors and patients frantically chased medicines for ailments like strep throat. Even children’s Tylenol was hard to find.Hundreds of drugs are on the list of medications in short supply in the United States, as officials grapple with an opaque and sometimes interrupted supply chain, quality and financial issues that are leading to manufacturing shutdowns.The shortages are so acute that they are commanding the attention of the White House and Congress, which are examining the underlying causes of the faltering generic drug market, which accounts for about 90 percent of domestic prescriptions.The Biden administration has assembled a team to find long-term solutions for shoring up the pharmaceutical supply chain, at a time when the United States remains heavily reliant on medicines and drug ingredients from India and China. And in recent weeks, generic drug makers, supply-chain experts and patient advocates have appeared before lawmakers to discuss the problems.The scarcity of generic forms of chemotherapy to treat lung, breast, bladder and ovarian cancers has only heightened concerns.“This is, in my opinion, a public health emergency,” said Dr. Amanda Fader, a professor at the Johns Hopkins School of Medicine and a president-elect of the Society of Gynecologic Oncology, “because of the breadth of the individuals it affects and the number of chemotherapy agents that are in shortage right now.”The American Cancer Society last week warned that delays caused by the shortages could result in worse outcomes for patients.“If these drugs are not available, people are going to get inferior care,” Dr. William Dahut, the society’s chief medical officer, said. “That’s the bottom line. These aren’t third- or fourth-line drugs where there are multiple other agents around. These are used up front for people you are trying to cure.”Ryan Dwars beat pancreatic cancer in 2021, but late last year a scan showed cancerous spots on his liver. Mr. Dwars, 39 and a father of two young girls, had hoped to receive his final four doses of chemotherapy in April.Then his doctor delivered stunning news: He didn’t make the cut of those given priority for the treatment.“The light at the end of the tunnel was within sight,” Mr. Dwars, a special education teacher in Iowa City, said. “It made it even worse to be so close — and now this.”Laura Bray, who founded a nonprofit called Angels for Change, works as a liaison among patients, health systems and drug companies to “micro-source,” as she calls it, hard-to-find medications.Dr. Robert Califf, the F.D.A. commissioner, said the agency had prevented a number of drug shortages. “Our employees can only plug a certain number of holes in a system which has got real problems,” he said.Julia Nikhinson/Reuters“Will we have the resolve and sense of urgency to fix this?’’ asked Ms. Bray, an adjunct business professor who has been providing information to the White House and Congress. “It’s possible. It can be done. It happens in other supply chains. But we have to focus on it and we have to think about ending it — instead of mitigating it. I think the jury’s out on that.”For Mr. Dwars, Ms. Bray contacted a maker of cisplatin, the chemo drug he needed and arranged for a supply to be sent within days and for others at his hospital. Some in states around the country have not been as fortunate, encountering frightening gaps between treatments.The White House team working on the broader issue of longstanding drug supply breakdowns includes national security, economic and health officials, according to James McKinney, a spokesman for the Food and Drug Administration. Bloomberg reported earlier on the White House involvement.Officials have been debating possible measures like tax incentives for generic drugmakers and greater transparency around generic drug quality. The current incentives favor drugmakers with the lowest prices, which includes those that might cut corners — leading to disruptive plant shutdowns if the F.D.A. demands a fix. (Some shortages, like those of weight-loss drugs, are the result of sky-high demand, while others have been attributed to overprescribing, including for antibiotics, or a lack of investment in potential alternatives.)The F.D.A., which employs a team of about 10 people who do the day-to-day work of mitigating and reporting drug shortages, has said it is seeking authority from Congress to get additional information about the drug manufacturing and supply chain.But the agency has also expressed its concerns to the White House about severe financial strain in the generic drug industry — an economic problem that F.D.A. officials say they are not suited to address.Dr. Robert Califf, the F.D.A. commissioner, highlighted the agency’s views during recent appearances before Congress, saying officials can only plug so many holes.“We have got to fix the core economics if we’re going to get this situation fixed,” Dr. Califf told a House panel on May 11.David Gaugh, the interim chief executive of the Association for Accessible Medicines, which represents generic drugmakers, recalled warning F.D.A. officials in an April meeting that the recent bankruptcy and shutdown of Akorn Pharmaceuticals would likely be followed by others.“Shortages are on the rise. We’ve all seen that,” Mr. Gaugh said in an interview. “And it is likely going to get worse, not better, very soon.”Mr. Gaugh cited data underscoring pressure facing the generic industry. Although the number of generic drugmakers has increased, a review by IQVIA, a health care analytics company, showed that the market has consolidated such that three buyers account for about 90 percent of generic drug purchases. The intermediaries are combined major drug distributors and retail chains, like Red Oak Sourcing, which includes CVS Health and Cardinal Health and ClarusONE, which includes Walmart and McKesson. Walgreens also has distribution agreements with AmerisourceBergen. The companies did not reply to requests for comment.The competition for the contracts with those intermediaries pits U.S. manufacturers against those in India, where labor costs are far lower. When a generic drug company can’t get a contract for a medication, it tends to stop making it and might see already-slim profits shrink.“The opportunity to get it wrong is much narrower if you’re a generic manufacturer,” Mr. Gaugh said.Hospital pharmacists and supply-chain experts were stunned in February by the abrupt shutdown of Akorn, whose products were then recalled since there was no staff remaining to address potential quality concerns.That added “insult to injury,” said Eric Tichy, a supply chain division chair at the Mayo Clinic and the board chairman of the End Drug Shortages Alliance.Akorn made roughly 100 medications, including cylinders of albuterol that children’s hospitals had relied on to ease their breathing difficulties. And it was the only company that made an antidote to lead poisoning, Dr. Tichy said.“Health is so foundational to our country functioning well,” Dr. Tichy said. “And then we have a domestic manufacturer that just goes under and there’s not a lot of action.”A respiratory therapist held a nebulizer with albuterol, one of the drugs manufactured by the shuttered pharmaceutical company Akorn, at a hospital in New Orleans.Erin Schaff/The New York TimesFour Senate bills with bipartisan sponsorship could help get generic drugs to market more quickly by addressing tactics or loopholes that cause delays. During a House hearing on the shortages Thursday, Anthony Sardella, a business research adviser at Washington University in St. Louis, said generic drug prices had fallen by about 50 percent since 2016.“But there is a high cost to low prices,” Mr. Sardella said, noting that they may lead to cost cutting that can result in quality problems.A recent case in point was Intas Pharmaceuticals, a company in India that makes three key chemotherapy drugs that are difficult to find: methotrexate, carboplatin and cisplatin, the drug Mr. Dwars needed. Intas temporarily suspended manufacturing of the drugs after the F.D.A. found serious quality-control violations.During an unannounced visit to the Intas plant, F.D.A. inspectors discovered a “truck full of” hundreds of plastic bags filled with torn and shredded documents, according to a report issued in December. One quality-control worker poured acid on torn records and stuffed them in a garbage bag, the report said.F.D.A. inspectors pieced papers together and found quality control records for products bound for the United States, the report said. The agency cited a raft of other problems as well.To ease the supply disruption, the U.S. distributor for Intas, Accord Pharmaceuticals, said a handful of lots were tested by a third party, certified and released to the U.S. market. The treatments arranged by Ms. Bray that reached patients in Iowa were among them.The companies were working with the F.D.A. to restart manufacturing for U.S. customers, a statement from Accord said, adding that it found the shredding to be an “isolated incident.”The Society of Gynecologic Oncology sent out a nationwide survey in recent weeks. In response, doctors in 35 states said they had little to no supply of key chemotherapy drugs, even at large cancer centers and teaching hospitals.Dr. Patrick Timmins, a partner of Women’s Cancer Care Associates in Albany, N.Y., said his practice ran out of some chemotherapy drugs on May 9, but still has 25 patients who need them.“Our patients are in a war, and what we’re doing is we’re taking their weapons away,” Dr. Timmins said. “It’s completely ridiculous that we can’t figure out a way, at least in the short run, to get our patients treated, and in the long run to solve these recurring problems.”When Ms. Bray met with White House staff members in late April, she said that she recommended creating an exchange, to get drugs where they were needed most, and increasing the production of small-batch medicines, often referred to as compounding.Dr. Kevin Schulman, a professor at Stanford Medicine who has studied the generic drug industry, said he had urged the White House team to examine how much power the intermediary companies have in contracting with generic drug makers. He said they demand rock-bottom prices, but unlike a customer-facing company like Apple that contracts with suppliers worldwide, the drug intermediaries face no accountability when shortages arise.Dr. Schulman said he had recommended expanded government contracting with the nonprofit Civica, which sells generic drugs at slightly inflated prices, which can help generic makers run a stable business.“The intermediaries are driving people out of the market,” Dr. Schulman said. “I think it’s a market problem and we need market-level solutions.”